Ranger Paclitaxel-Coated PTA Balloon Catheter

FDA Premarket Approval P190019 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Replacement of the current software with new software to collect and process manufacturing test data

DeviceRanger Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Date Received2020-11-09
Decision Date2020-11-12
PMAP190019
SupplementS002
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Boston Scientific Corporation three Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P190019Original Filing
S002 2020-11-09 30-day Notice
S001

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